FDA Inspection 1268693 — Talecris Plasma Resources (Biomat USA, Inc.)
The FDA completed an inspection of Talecris Plasma Resources (Biomat USA, Inc.) on May 1, 2025 in El Paso, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- El Paso, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 333 | 21 CFR 640.64(e) | Prevention of contamination |